Phase III Study Comparing Contact X-ray Brachytherapy Plus Total Neoadjuvant Therapy Versus Total Neoadjuvant Therapy Alone for Rectal Preservation in Adults with Intermediate Rectal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the addition of contact X-ray brachytherapy CXB to total neoadjuvant therapy TNT in adults with intermediate low or mid rectal adenocarcinoma. The goal is to increase survival while preserving the rectum in patients with tumors sized between 3.1 to 6 cm and specific clinical stages cT2N1 or T3N0-1, M0. This is an open-label, phase III randomized controlled trial comparing two treatment approaches. One group receives standard TNT with six cycles of modified FOLFIRINOX chemotherapy over 12 weeks followed by neoadjuvant chemoradiotherapy nCRT consisting of 50 Gy radiation over 5 weeks with concurrent capecitabine. The experimental group receives the same TNT regimen plus three fractions of CXB given every two weeks between the end of chemotherapy and the start of nCRT. After treatment, patients undergo clinical, endoscopic, and radiological evaluations. Seven weeks post-nCRT, patients with a complete clinical response may have local excision or be monitored, depending on center preference. Those without complete response will have total mesorectal excision TME surgery followed by adjuvant chemotherapy with either mFOLFOX or capecitabine for 12 weeks. The main outcome is survival with organ preservation assessed 15 months after the first patient is included. Participants will have regular monitoring and assessments throughout the study.

Evaluation Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma